OPTIGLAZE™ 008423

GUDID 14548161292115

OPTIGLAZE™ Color Red (2.6 mL)

Gc America Inc.

Dental unfilled resin sealant/coating

• Primary Device ID: 14548161292115
• NIH Device Record Key: 2a4f581e-b101-4453-b970-ac810188f5a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIGLAZE™
• Version Model Number: 008423
• Catalog Number: 008423
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Device Dimensions

• Total Volume: 2.6 Milliliter
• Total Volume: 2.6 Milliliter
• Total Volume: 2.6 Milliliter
• Total Volume: 2.6 Milliliter
• Total Volume: 2.6 Milliliter
• Total Volume: 2.6 Milliliter
• Total Volume: 2.6 Milliliter
• Total Volume: 2.6 Milliliter
• Total Volume: 2.6 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	14548161292115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133836

FDA Product Code

• EBD: Coating, filling material, resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-15
• Device Publish Date: 2022-08-05

On-Brand Devices [OPTIGLAZE™]

• 04548161391941: Optiglaze™ Brush Holder, 2 pieces per box
• 04548161391934: Optiglaze™ Brush Round #1, 10 pieces per box
• 04548161391927: Optiglaze™ Brush Flat #1, 10 pieces per box
• 14548161292122: OPTIGLAZE™ Color Clear HV (5 mL)
• 14548161292115: OPTIGLAZE™ Color Red (2.6 mL)
• 14548161292108: OPTIGLAZE™ Color Pink (2.6 mL)
• 14548161292092: OPTIGLAZE™ Color Lavender (2.6 mL)
• 14548161292085: OPTIGLAZE™ Color Olive (2.6 mL)
• 14548161292078: OPTIGLAZE™ Color Pink Orange (2.6 mL)
• 14548161292061: OPTIGLAZE™ Color Yellow (2.6 mL)
• 14548161292054: OPTIGLAZE™ Color White (2.6 mL)
• 14548161292047: OPTIGLAZE™Color C plus (2.6 mL)
• 14548161292030: OPTIGLAZE™ Color B plus (2.6 mL)
• 14548161283359: OPTIGLAZE™ Color Red Brown (2.6 mL)
• 14548161283342: OPTIGLAZE™ Color Orange (2.6 mL)
• 14548161283335: OPTIGLAZE™ Color Ivory White (2.6 mL)
• 14548161283328: OPTIGLAZE™ Color Grey (2.6 mL)
• 14548161283311: OPTIGLAZE™ Color Clear (5 mL)
• 14548161283304: OPTIGLAZE™ Color Blue (2.6 mL)
• 14548161283298: OPTIGLAZE™ Color A plus (2.6 mL)
• 14548161282765: OPTIGLAZE™Color Complete Set Contains: All color shades (2.6 mL each) and disposable palette
• 14548161282574: OPTIGLAZE™ OPTIGLAZE Contains: One (15 mL) bottle.